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Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144612
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 23, 2009
Information provided by:
Chugai Pharmaceutical

Brief Summary:
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Condition or disease Intervention/treatment Phase
Systemic Juvenile Idiopathic Arthritis Drug: MRA(Tocilizumab) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP
Study Start Date : July 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1 Drug: MRA(Tocilizumab)

Primary Outcome Measures :
  1. Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) [ Time Frame: whole period ]
  2. Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ]
  3. Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ]

Secondary Outcome Measures :
  1. Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria (MRA011JP patients)

  • Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
  • the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
  • Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
  • Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

  • Patients who were not enrolled by 3 months after completion of the previous study
  • Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144612

Sponsors and Collaborators
Chugai Pharmaceutical
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Study Director: Takahiro Kakehi Chugai Pharmaceutical
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chugai Pharmaceutical Identifier: NCT00144612    
Other Study ID Numbers: MRA317JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases